5444-0-200

GUDID 07613252133544

CMF CUSTOMIZED IMPLANT KIT MEDIUM

Howmedica Osteonics Corp.

Cranioplasty plate, non-alterable
Primary Device ID07613252133544
NIH Device Record Keyf71ae358-8b6e-4327-bcc3-d331c4847e85
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5444-0-200
Catalog Number5444-0-200
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613252133544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKYMATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

Devices Manufactured by Howmedica Osteonics Corp.

07613327597448 - TRIATHLON GOLD2025-11-28 CRUCIATE RETAINING FEMORAL
07613327597455 - TRIATHLON GOLD2025-11-28 CRUCIATE RETAINING FEMORAL
07613327597509 - TRIATHLON GOLD2025-11-28 CRUCIATE RETAINING FEMORAL
07613327597516 - TRIATHLON GOLD2025-11-28 CRUCIATE RETAINING FEMORAL
07613327597578 - TRIATHLON GOLD2025-11-28 CRUCIATE RETAINING FEMORAL
07613327597585 - TRIATHLON GOLD2025-11-28 CRUCIATE RETAINING FEMORAL
07613327597592 - TRIATHLON GOLD2025-11-28 CRUCIATE RETAINING FEMORAL
07613327597639 - TRIATHLON GOLD2025-11-28 CRUCIATE RETAINING FEMORAL

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